(11 days)
The Signature Edition Infusion System (infusion pumps and administration sets) is intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products.
The Signature Edition Infusion System is indicated for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces.
This device is essentially the same as the originally submitted devices (the predicate devices), filed as Models EZ 1 and EZ 2 Infusion Pumps (K931549) and EZ Administration Set Series (K931550). The electrical volumetric pumps and administration sets are used to control the rate or monitor the flow of solution or medication for delivery of drugs, fluids, and blood products. In general, infusion systems are used when the solution to be administered needs to be delivered with greater accuracy or at a higher flow than can be provided through a manually adjusted gravity administration set. Because they allow more accurate fluid delivery, infusion systems have been proven to be useful in applications such as continuous epidural anesthesia, administration of IV cardiovascular drugs, chemotherapy, and blood transfusions.
This document (K032147) is a 510(k) premarket notification for the "Signature Edition Infusion System," which is essentially the same as predicate devices (EZ 1 and EZ 2 Infusion Pumps and EZ Administration Sets) with minor changes. The submission primarily focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than presenting a study of its own performance against pre-defined acceptance criteria.
Therefore, the requested information regarding acceptance criteria and performance data for a new study validating the device's performance is not available within this document. The document explicitly states: "The changes as described in this Special 510(k) pose no new issues of safety or efficacy." This implies that extensive new performance studies (especially those with detailed acceptance criteria, expert adjudication, MRMC studies, or standalone performance data) were not deemed necessary because the device is substantially equivalent to already approved devices.
Here's an explanation based on the provided text, acknowledging the lack of specific performance study details:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document asserts that the "Signature Edition Infusion System is essentially the same as the predicate devices," (EZ 1 and EZ 2 Infusion Pumps, K931549, and EZ Administration Sets, K931550). The implication is that the performance of the Signature Edition Infusion System would meet the same performance metrics and acceptance criteria as its predicate devices, but these specific metrics are not detailed in this 510(k) summary. The document states: "The results of this comparison demonstrate that the Signature Edition Infusion System is equivalent in technological characteristics and the fundamental scientific technology of the predicate devices has not been altered." This suggests that previous studies for the predicate devices established their performance, and this current submission relies on that equivalence.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not provided in the document. Since this is a 510(k) for substantial equivalence to predicate devices with "no new issues of safety or efficacy," extensive new performance testing with specific sample sizes might not have been required or documented here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable as the device is an infusion system, not an AI-assisted diagnostic tool. No MRMC study was mentioned or implied.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is an infusion system, not an algorithm. Standalone performance for its intended function (fluid and medication delivery) would be evaluated based on flow rate accuracy, pressure limits, safety features, etc., but specific studies demonstrating this are not detailed in this summary. The fundamental scientific technology has not been altered, implying prior validation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not provided in the document for new testing of this specific device. For the predicate devices, "ground truth" would likely refer to established engineering and physiological standards for infusion accuracy, safety alarms, material compatibility, and reliable fluid delivery, as demonstrated in their original submissions.
8. The sample size for the training set:
This information is not provided in the document. This is not an AI/algorithm-based device that would typically have a "training set."
9. How the ground truth for the training set was established:
This information is not provided in the document. As stated above, this is not an AI/algorithm-based device.
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JUL 25 2003
SIGNATURE EDITION INFIJSION SY
ATTACHMENT D
SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems, Inc. Signature Edition Infusion System
| SUBMITTER'S NAME: | ALARIS Medical Systems, Inc.10221 Wateridge CircleSan Diego, CA 92121-2772(858) 458-7830(858) 458-6114 FAX |
|---|---|
| ------------------- | ---------------------------------------------------------------------------------------------------------------------------- |
CONTACT PERSON: Stacy L. Lewis Regulatory Affairs Associate
July 10, 2003 DATE PREPARED:
DEVICE NAME: Proprietary Name Signature Edition Infusion System
Common Name Infusion Pump IV Administration Sets
Classification Name Pump. Infusion and accessories, FRN (880.5725) Administration Sets, Intravascular, FPA (880-5440)
DEVICE DESCRIPTION
This device is essentially the same as the originally submitted devices (the predicate devices), filed as Models EZ 1 and EZ 2 Infusion Pumps (K931549) and EZ Administration Set Series (K931550). The electrical volumetric pumps and administration sets are used to control the rate or monitor the flow of solution or medication for delivery of drugs, fluids, and blood products. In general, infusion systems are used when the solution to be administered needs to be delivered with greater accuracy or at a higher flow than can be provided through a manually adjusted gravity administration set. Because they allow more accurate fluid
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SUMMARY OF SAFETY AND EFFECTIVENESS Page 2 of 2
delivery, infusion systems have been proven to be useful in applications such as continuous epidural anesthesia, administration of IV cardiovascular drugs, chemotherapy, and blood transfusions. See Section 5 for a detailed device description and comparison.
SUBSTANTIAL EQUIVALENCE
The Signature Edition Infusion System is essentially the same as the predicate devices in that they have the same intended use, operating principles, technological design, incorporate similar materials and manufacturing processes. The changes as described in this Special 510(k) pose no new issues of safety or efficacy. The Signature Edition Infusion System as described in this submission is substantially equivalent to the predicate devices. See Section 6 for substantial equivalence details and a comparison table.
INTENDED USE
The intended use of this device has not changed from the original submissions in terms of content or intent. The Signature Edition Infusion System (infusion pumps and administration sets) is intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products. A separate Indications for Use statement is provided in Attachment B.
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the Signature Edition Infusion System and the predicate devices has been performed. The results of this comparison demonstrate that the Signature Edition Infusion System is equivalent in technological characteristics and the fundamental scientific technology of the predicate devices has not been altered.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol that resembles a stylized human figure or a caduceus, with three curved lines representing the body and a wavy line at the bottom.
Public Health Service
JUL 2 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Stacy L. Lewis Regulatory Affairs Associate Alaris Medical Systems Incorporated Worldwide Headquarters 10221 Wateridge Circle San Diego, California 92121-2772
Re: K032147
Trade/Device Name: Signature Edition Infusion Pump Regulation Number: 880.5275, 880. 5440 Regulation Name: Infusion Pump and Administration Set Regulatory Class: II Product Code: FRN, FPA Dated: July 10, 2003 Received: July 14, 2003
Dear Ms. Lewis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, and Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Lewis
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
S.A. Winchester
for
Susan Runner, DDDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment B
INDICATIONS FOR USE
510(k) Number: (To Be Assigned By FDA)
Device Trade Name: Signature Edition Infusion System
Indications For Use:
The Signature Edition Infusion System (infusion pumps and administration sets) is intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products.
The Signature Edition Infusion System is indicated for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE). The Concertion (Carro as the | |
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(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
5100 Number. K032147
Prescription Use __ U
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).